This Memorandum of Understanding (MOU) documents the affiliation among the Walter Reed Army Institute of Research (“the Institute”), the F. Edward Hébert School of Medicine (“the School”), and the Food and Drug Administration (“FDA”) in the established Clinical Pharmacology Fellowship Training Program (“the Program”). This affiliation permits the coordination of resources to develop a unified program, maximize efficient utilization of government facilities, and strengthen the joint education and research efforts among the parties.

II.Background:

Military and civilian elements within the Federal Government are separately empowered and funded by Congressional Acts. In working together, they must accommodate legal and monetary restrictions, and assure that each party receives mission benefit from any Agreements arranged.

III.Statement of Authority:

A.FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended (21 U.S.C. 301). In fulfilling its responsibilities under the Act, FDA among other things, directs its activities toward promoting and protecting the public health by assuring the safety, efficacy, and security of drugs, veterinary products, medical devices and radiological products and the safety and security of foods and cosmetics. In addition, in accordance with its regulations at 21 C.F.R. 20.85, FDA may disclose to other Federal government departments and agencies non-public information subject to certain limitations.

B.The School is authorized to enter into such agreements by Public Law 92-426, Title 10 Section 2112, 2113, 2114 and Department of Defense Instruction 5105.45.

C.The Institute authority is established by DOD Instruction 4000.19, Interservice and Intergovernmental Support, 9 August 1995 and AR 351-3 Professional Education and Training Programs of the Army Medical Department, 15 October 2007.

IV.Substance of Agreement:

The Program consists of two years of training. Fellows may be selected and trained at each year level. Fellows shall be Medical Corps officers on active duty in the U.S. Army, the U.S. Navy, the U.S. Air Force, or the U.S. Public Health Service. Additionally, civilian fellows may also be trained when there is an available and authorized source of funding after proper justification of benefit to the Federal Government. There shall be no discrimination against any individual engaged in the work covered by this agreement because of race, creed, color, national origin, sex, sexual preference, ancestry, age, or handicap to the extent that Federal laws prohibiting such discrimination apply to the Institute, School and FDA. This MOU involves the combined and coordinated efforts of the parties to the MOU, and is only amenable to separation of responsibilities as noted below:

A. The School and the Institute will coordinate the technical and support personnel involved in the Program. FDA’s contribution to the Program will be to offer a two-month to four-month rotation to second-year fellows and potentially clinical pharmacology staff who have not had this component as part of their training. Each party will provide qualified civilian or uniformed personnel who are assigned to serve as mentors. The Institute, School, and FDA will not compensate or reimburse the other on account of any of the activities, services, or facilities provided by the other in accordance with this agreement.

B. Academic Appointments:

i. Members of the Institute and FDA’s clinical staff, who in accordance with the standards and procedures prescribed by the University for appointment to the faculty of the University’s F. Edward Hébert School of Medicine (SOM) qualify by training and performance, may be considered for appropriate appointments to the University faculty.

ii. Qualifying staff members of the Institute and FDA’s medical staff, on the approval of the Institute, FDA and the School, through the approved appointment mechanisms of the School, will receive academic titles and have the same rights and privileges as other holders of academic appointments from the School.

iii. All members of the Institute and FDA staff holding faculty appointments, in addition to their primary positions in the Institute and FDA, will be considered faculty. They will perform their Institute and FDA staff duties in accordance with the rules and organizational structure, and under the direction of the Institute and FDA. Such members also will coordinate with and report to the appropriate Department Chairperson (or designee) of the School on all academic activities relating to their faculty appointment.

iv. Faculty will be responsible for teaching programs at the undergraduate, graduate, and postgraduate level within the teaching service at the Institute, School, and FDA and will coordinate with the Department Chairperson or his/her representative. Faculty will have access to appropriate resources for student education.

C. The Program’s Fellows will be directly responsible to and under the direction of the Co-directors of the Program at the School and at the Institute.

D. The Co-directors of the Clinical Pharmacology Fellowship Training Program will be responsible for the direction of all Fellows.

E. Clinical Exposure/Supervision:

i. Fellows and staff shall abide by all of the policies, rules, and regulations of the Institute and FDA. The parties agree that the Fellows will be considered providers or members of the Institute and FDA’s workforce while performing duties pursuant to this agreement, and so do not meet the definition of business associates under the Health Insurance Portability and Accountability Act of 1996, as codified at 42 U.S.C. Section 1320d (“HIPAA”). No business associate agreement between the parties, therefore, is necessary. The School and Institute will train the Fellows on the protection and privacy of protected health information and will provide evidence of such training to FDA as required. Such training will meet the requirements of HIPAA and its privacy rules, and of DoD 6025.18, DoD Health Information Privacy Regulation, dated 24 January 2003. School trainees and faculty shall abide by applicable HIPAA policies. No protected healthcare information is anticipated to be exchanged between the Institute, the School, and FDA.

ii. While Fellows are not expected to have contact with patients at FDA, if Fellows have such contact , they shall be under the direction of the staff and assigned teaching attending staff who hold faculty appointments.

iii. Any FDA staff or Fellows participating in an investigational study under this Program involving human subject must comply with all applicable regulations governing informed consent.

iv. Agency coordination will be conducted to provide Institutional Review Board oversight for all human research protocols under this Program.

v. FDA will facilitate assessment of FDA facilities by government agencies or other agencies charged with the responsibility for accreditation of School education programs.

vi.Subject to mutual agreement between the leadership of the Institute, School, and FDA, FDA will provide necessary education facilities and access to appropriate resources for all Fellows participating in educational experiences within the Program.

viii. FDA will ensure that Fellows who are accidentally exposed to environmental hazards and/or infectious diseases and/or other occupational injury are treated appropriately and in a timely manner. FDA also will notify the School, which will arrange for follow–up care as needed at the School’s Health Clinic or elsewhere, as appropriate.

ix. FDA will investigate complaints regarding unprofessional behavior by the Fellow(s). It will forward any findings, conclusions, or recommendations to the sponsoring program and to the School for appropriate action (to include academic or legal action).

F. FDA’s Center for the Drug Evaluation and Research will arrange the following rotations:

1) Office of New Drugs (OND)

The Office of New Drugs will work with the co-Directors of the Clinical Pharmacology Fellowship Training Program to schedule a two-month to four-month internship in the area of interest for second-year Fellows. During this internship, a member of the Office of New Drugs or the appropriate office or review division hosting the internship will be assigned as a mentor (team leader or reviewer) to the Fellow during the period of training. The Fellows will attend Office of New Drugs and related review division briefings and other scientific activities. Reviews by the Fellow of protocols and study reports will be conducted under appropriate supervision. Involvement of Fellows in these reviews will only be to the extent permitted under applicable statutes and regulations. The internship should be arranged to allow the Fellow to participate in educational activities sponsored by FDA such as the bimonthly scientific seminar, the annual Academics to the Center for Drug Evaluation and Research course and, if possible, the New Drug Application (NDA) or Investigational New Drug (IND) review course. The Fellows will be encouraged to conduct reviews of NDAs, Biologic License Applications (BLAs), or INDs to the extent permitted under applicable statutes and regulations. Except under unusual circumstances, each fellow will participate actively in the review of an IND or NDA or BLA application under the mentorship of an FDA reviewer during his/her rotation at FDA.

2) Office of Clinical Pharmacology (OCP)

The Office of Clinical Pharmacology will work with the Co-Directors of the Clinical Pharmacology Fellowship Training Program to schedule a two- to four-month rotation in the therapeutic area of interest for second-year Fellows. Arrangements for these rotations between OCP and the Co-Directors should be finalized at least 3 months prior to the initiation of a rotation. In addition, the Co-Directors of the Clinical Pharmacology Fellowship Training Program shall provide the FDA Office of Clinical Pharmacology information regarding the specific goals and objectives that each of the incoming Fellows would like to attain during the rotation.

During this rotation, a member of the immediate Office of Clinical Pharmacology or the review division hosting the rotation will be assigned as a mentor to the Fellow during the period of training. The Fellows will attend related review division briefings and other scientific activities. Reviews by the Fellow of protocols and study reports will be conducted under appropriate supervision. Involvement of Fellows in these reviews will only be to the extent permitted under applicable statutes and regulations. The rotation should be arranged to allow the Fellow to participate in educational activities sponsored by FDA. The Fellows will be encouraged to conduct any reviews of New Drug Applications, Biologic License Application or Investigational New Drugs to the extent permitted under applicable statutes and regulations.

G. Liability/Contingency - The parties recognize that faculty, staff, and Fellows performing pursuant to this agreement remain employees of their respective services and of the United States, performing duties within the course and scope of their Federal employment. Consequently, the provisions of the Federal Tort Claims Act (Title 28, USC § 2671 et seq.), including its defenses and immunities, will apply only and exclusively to allegations of negligence or wrongful acts or omissions by faculty, staff, and Fellows while acting within the scope of their duties as Federal employees, pursuant to this agreement. The primary responsibility for investigating tort claims arising from the period of instruction at FDA shall reside in the General Law Division of the Department of Health and Human Services. FDA will notify the School General Counsel (telephone 301.295.3028) of any actual or potential claim or suit against the Institute and FDA that names a member or employee of the School as a party or potential defendant.

H. Publication of any materials where School faculty, trainees, or Institute and/or FDA staff members participated in the development of a scientific and/or clinical project as a result of shared experience must be authorized in accordance with all parties applicable statutes, regulations and policies.

I. The foregoing represents the broad outline of the agreements of the parties to engage in collaborative training efforts. All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, and funds and are further subject to applicable statutes and regulations. This MOU does not affect or supersede any existing or future arrangements among the parties and does not affect the ability of the parties to enter into other agreements or arrangements related to this MOU.

J. The parties acknowledge and agree that the Fellows shall only be provided access to non-public information as necessary to perform their official duties in accordance with this MOU and any such non-public information is shared by FDA pursuant to 21 CFR 20.85. The Institute and the School agree that any non-public information provided to a Fellow will not be further released, published, or disclosed by the Fellow, the School, or the Institute. and that they shall protect such information in accordance with the Trade Secrets Act, 18 USC 1905, the Food, Drug, and Cosmetic Act, 21 USC 301 et seq., the Privacy Act of 1974, as amended, 5 USC 552a, and the Freedom of Information Act, 5 USC 552, and other pertinent laws and regulations governing the confidentiality of non-public information. In addition, the parties agree that the Fellows will execute and abide by all requirements of the Commitment to Protect Non-Public Information (Form FDA 3398) and will provide a copy of a Confidential Financial Disclosure Report (OGE 450) to the Co-Directors of the Clinical Pharmacology Fellowship Training Program. The parties also acknowledge and agree that, pursuant to section 301(j) of the Food, Drug, and Cosmetic Act, 21 USC 331(j), FDA will not provide to the Fellows, and the Fellows are not authorized to have access to, any method or process that is entitled to protection as a trade secret.

V.Eligibility Requirements

The parties agree that they will abide by all requirements of the American Board of Clinical Pharmacology, including, but not limited to, those involving the supervision of Fellows, Fellows’ work hours, and Fellows’ work environment. The minimum academic and professional qualifications to enter the program are a Ph.D., M.D, D.O. or Pharm.D, degree from an accredited institution, and, for applicants with the M.D. or D.O. degree, training and board eligibility in a medical specialty.

VI. Coverances

Fellows participating in the MOU should be United States Citizens or Permanent Residents. Regarding the latter, all federal restrictions will be adhered to.

VII.MOU POCs:

Jasleen Shant Ph.D.

Senior Technology Transfer Officer

Office of Research and Technology Applications (ORTA),

Room1W58

The Walter Reed Army Institute of Research

503 Robert Grant Avenue

Silver Spring, MD 20910-7500

Nisha Bruce, Contract Liaison Specialist

Food and Drug Administration

Center for Drug Evaluation and Research

Office of Translational Sciences

10903 New Hampshire Avenue White Oak Building 21 | Room 4519

Silver Spring, MD 20993

Tel: 301-796-4845 | Fax: 301-796-9907

E-Mail: nisha.bruce@fda.hhs.gov

Vice President for Affiliations and International Affairs

Uniformed Services University of the Health Sciences

4301 Jones Bridge Road

Bethesda, MD 20814

VIII. Program Directors:

For the Walter Reed Army Institute of Research:For the F. Edward Hébert School of Medicine:

COL Colin K. Ohrt, M.D., M.P.H.Louis R. Cantilena, M.D., Ph.D.

U.S. Army Program Director Director, Division of Clinical Pharmacology

For the Food and Drug Administration:For the Food and Drug Administration:

Russell G. Katz, M.D.Shiew-Mei Huang, Ph.D.

Center for Drug Evaluation and Research Center for Drug Evaluation and Research

Office of New Drugs Deputy Director, Office of Clinical Pharmacology

Office of Drug Evaluation I White Oak Building 51, Room 3188

Director, Division of Neurology Products 10903 New Hampshire Avenue

White Oak, Building 22, Room 4332 Silver Spring, Maryland 20993

10903 New Hampshire Avenue Phone: 301-796-5008

Silver Spring, MD 20993

301-796-2250

IX. Period of Agreement

A. The terms of this agreement shall be effective for a period of five (5) years from the date of execution (date of last signature). In the event of an administrative delay in renewing the agreement, there shall be an automatic one (1) year renewal, unless either party notifies the other party, in writing, not less than six (6) months prior to this agreement's termination date that either party does not wish to renew this agreement.

B. This agreement will be accepted by all participating partners. This agreement may be modified or terminated by mutual written consent by the partners or may be terminated by either partner(s) upon a 60-day advance written notice to the other. Efforts will be made to accommodate completion of training for Fellows onsite during termination.